TY - JOUR T1 - Formulation, stability and analytical method validation of peppermint oil solution AU - Demirbolat, İlker PY - 2019 DA - June JF - Natural Volatiles and Essential Oils JO - Nat. Volatiles & Essent. Oils nveo.org PB - Badebio Biotechnology Ltd. WT - DergiPark SN - 2148-9637 SP - 25 EP - 31 VL - 6 IS - 2 LA - en AB - Tension type headache is the most common type ofheadaches causing mild, moderate and intense pain in the forehead and neck. Thereare prescription medicines -usually nonsteroidal anti-inflammatory drugs- andherbal remedies to alleviate the pain. As peppermint (Mentha piperita L.) is one of those most used medicinal plants inthe world, essential oil has also a wide range of medical applications liketension type headache. The legislation to conventional medicines applies toherbal medicinal products too, which makes registered herbal medicinal productsreliable in production and quality. A CTD application dossier which contains productionand quality control data in module three should be provided while registering aproduct in European Union. In this study a peppermint oil solution is developedand analytical method is validated to control the stability of solutionindicated for tension type headaches. KW - Peppermint KW - Mentha piperita L. KW - Analytical Method Validation KW - Formulation CR - Asao, T., Mochiki, E., Suzuki, H., Nakamura, J., Hirayama, I., Morinaga, N., Shoji, H., Shitara, Y., & Kuwano, H. (2001). An easy method for the intraluminal administration of peppermint oil before colonoscopy and its effectiveness in reducing colonic spasm. Gastrointestinal Endoscopy, 53(2), 172-177. CR - Community Herbal Monograph on Mentha x piperita L., Aetheroleum (2007). Europhean Medicine Agency. London. CR - Davies, S. J., Harding, L. M., & Baranowski, A. P. (2002). A novel treatment of postherpetic neuralgia using peppermint oil. The Clinical Journal of Pain, 18(3), 200-202. CR - European Pharmacopoeia (2013). Peppermint Oil, 07/2012:0405. 8th ed. European Pharmacopoeia. European Directorate for the Quality of Medicines and Healthcare. Strasbourg: 1353-1354. CR - Evans, M. (1991). Herbal Plants, History and Use. London: Studio Editions. CR - Giachetti, D., Taddei, E., & Taddei, I. (1986). Pharmacological Activity of Mentha piperita, Salvia officinalis and Rosmarinus officinalis Essences on Oddi’s sphincter. Planta Medica, 52(6), 543-544. CR - Gobel, H., Fresenius, J., Heinze, A., Dworschak, M., & Soyka, D. (1996). Effectiveness of Oleum menthae piperitae and paracetamol in therapy of headache of the tension type. Der Nervenarzt ,67(8), 672-681. CR - Graves, R. (1955). The Greek Myths I. London: Penguin Books. CR - Grigoleit, H. G., & Grigoleit, P. (2005). Peppermint oil in irritable bowel syndrome. Phytomedicine ,12(8), 601-606. CR - Grimal, P. (1996). The Dictionary of Classical Mythology. New Jersey: Wiley-Blackwell. CR - Hiki, N., Kurosaka, H., Tatsutomi, Y., Shimoyama, S., Tsuji, E., Kojima, J., Shimizu, N., Ono, H., Hirooka, T., Noguchi, C., Mafune, K., & Kaminishi, M. (2003). Peppermint oil reduces gastric spasm during upper endoscopy: a randomized, double- blind, double-dummy controlled trial. Gastrointestinal Endoscopy, 57(4), 475-482. CR - ICH Q1A(R2); Stability Testing of New Drug Substances and Products (2003). International Conference on Harmonization. Geneva, Switzerland. CR - ICH Q2 (R1); Validation of Analytical Procedures: Text and methodology (2005). International Conference on Harmonization. Geneva, Switzerland. CR - İşcan, G., Kirimer, N., Kürkcüoglu, M., & Demirci, F. (2002). Antimicrobial Screening of Mentha piperita Essential Oils. Journal of Agricultural and Food Chemistry, 50, 3943−3946. CR - Morice, A. H., Marshall, A. E., Higgins, K. S., & Grattan, T. J. (1994). Effect of inhaled menthol on citric acid induced cough in normal subjects. Thorax, 49(10), 1024-1026. CR - Pimentel, M., Bonorris, G. G., Chow, E. J., & Lin, H. C. (2001). Peppermint oil improves the manometric findings in diffuse esophageal spasm. Journal of Clinical Gastroenterology, 33(1), 27-31. CR - USP 41-NF 36 Validation of Compendial Procedures. (2016). United States Pharmacopeial Convention. Rockville MD, USA UR - https://dergipark.org.tr/en/pub/nveo/issue//541700 L1 - https://dergipark.org.tr/en/download/article-file/784301 ER -